Cervical cancer is the second most common cancer in women worldwide and currently approximately a quarter of women with the disease are under the age of 35. As with all cancers, early detection and treatment results in a greater chance of successful treatment. Cervical smear tests have proven to be an effective method for detecting precursor lesions of cervical cancer. To conduct such a test, a sample of cells is taken using a spatula or brush to remove the top layer of cells from the cervix. The cells obtained are then ‘smeared’ onto a glass slide, fixed with a preservative solution and sent to a laboratory for examination. It is recommended that women have a smear test every 3 years. Tests are currently performed by nurses, doctors and other qualified health practitioners.
However, the smear test is not fulfilling its potential, as uptake by women is lower than desirable and also many women delay taking the test so that the interval between tests is longer than recommended. Factors involved in not taking, or delaying, a test include the stress of having such a test done and women being too busy to arrange and attend an appointment. Performing the test also takes up lots of health practitioner time, presenting a significant drain on the health service. If a sample is deemed to be inadequate, for example due to the presence of blood or an insufficient number of cells, a second smear test needs to be performed.
A speculum is a device used by a health practitioner to open the vagina to assist in gaining access to the cervix; it is usually made of plastic or metal and has two blades, connected by a hinge mechanism and handles to move the blades apart. Thus the blades are moved between an open and closed position by means of a scissor mechanism and may be locked into an open position by a screw thread. The speculum is also used for internal examinations. It is designed for use by a medical practitioner on a patient. The handles are shaped and positioned for use by the medical practitioner, making the device awkward, if not impossible, for the patient herself to hold and operate it. The handles may also restrict the space the health practitioner has when obtaining the sample or performing an internal examination. Further, both hands are required to operate the device.
Currently it is the norm to use an electric lamp having a directable lighting source located behind the health practitioner to provide illumination for the examination or to collect the cervical sample. The health practitioner can therefore obscure the light and cast a shadow on the patient.
WO2004/039252 discloses a vaginal speculum wherein the handle may be disconnected from the blade module once the blades have been inserted in to the vagina and are locked in an open position.
Other designs of specula also exist, such as a surgical speculum with four blades, as described in US2005113644.
WO96/28083 discloses a speculum having four blades that are each held in a housing having a circular opening. The blades are spaced around the opening and they are pivotable with respect to the housing to move the tips of the blade outwards and so open an inspection channel through the speculum that includes the circular opening. The axis about which the blades pivot is located part of the way along the blade length and the inner end of each blade is in contact with a cam ring that is rotatable around the opening, The cam ring has cam surfaces that engage the inner ends of the blades to move them inwards and so pivot the blades about the axis and move the tips of the blades outwards to open the inspection channel. The patent requires a retaining ring to hold the blades in place. Thus the device requires a large number of pieces that have to be fitted together and hence is both expensive to make and to assemble, particularly for a disposable item.
U.S. Pat. No. 5,509,893 discloses a speculum having at least two dilator blades that are each held between an annular support member and a collar so that each blade can be pivoted about an axis part of the way along its length. The support member has a circular opening and the blades are spaced around the opening. When the tips of the blades are pivoted outward, an inspection channel is opened through the speculum that extends through the circular opening and the space between the blades. A cam ring that is rotatable around the opening and has a cam surface engages the inward part of the blade, i.e. away from the tip, and the rotation of the ring causes the cam surface to pivot the blades. The cam ring is held in place by a ratchet and pawl arrangement. The device requires a large number of pieces that have to be fitted together and hence is both expensive to make and to assemble, particularly for a disposable item.
One of the aims of both WO96/28083 and U.S. Pat. No. 5,509,893 is to make a disposable speculum that can be used once and then thrown away. An important aspect of the design of disposable medical item is that it must be made as cheaply as possible, while still fulfilling its function. Nevertheless, even with a two-blade version of the speculums described in these two specifications, the devices must be made using a minimum of five separate pieces and assembly of the pieces is time-consuming and fiddly and therefore the speculums are expensive.